Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules

Abstract

BACKGROUND Concern persists that extended shifts in medical residency programs may adversely affect patient safety. METHODS We conducted a cluster-randomized noninferiority trial in 63 internal-medicine residency programs during the 2015–2016 academic year. Programs underwent randomization to a group with standard duty hours, as adopted by the Accreditation Council for Graduate Medical Education (ACGME) in July 2011, or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts. The primary outcome for each program was the change in unadjusted 30-day mortality from the pretrial year to the trial year, as ascertained from Medicare claims. We hypothesized that the change in 30-day mortality in the flexible programs would not be worse than the change in the standard programs (difference-in-difference analysis) by more than 1 percentage point (noninferiority margin). Secondary outcomes were changes in five other patient safety measures and risk-adjusted outcomes for all measures. RESULTS The change in 30-day mortality (primary outcome) among the patients in the flexible programs (12.5% in the trial year vs. 12.6% in the pretrial year) was noninferior to that in the standard programs (12.2% in the trial year vs. 12.7% in the pretrial year). The test for noninferiority was significant (P = 0.03), with an estimate of the upper limit of the one-sided 95% confidence interval (0.93%) for a between-group difference in the change in mortality that was less than the prespecified noninferiority margin of 1 percentage point. Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also below 1 percentage point; the noninferiority criterion was not met for 30-day readmissions or prolonged length of hospital stay. Risk-adjusted measures generally showed similar findings. CONCLUSIONS Allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety. (Funded by the National Heart, Lung, and Blood Institute and Accreditation Council for Graduate Medical Education; iCOMPARE ClinicalTrials.gov number, NCT02274818.)

Day-to-day variability in sleep parameters and depression risk: a prospective cohort study of training physicians

“…The potential impact of relaxing duty hour restrictions was assessed in the Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, which recently demonstrated that chronic sleep loss and sleepiness were similar among interns in flexible programs and standard programs 44 . Further, no detriment to patient safety outcomes was observed 45 . However, by leveraging current technological advances of multisensory consumer sleep trackers and digital, momentary mood assessments, we were able to detail more granular relationships between sleep, depression, and daily mood which reveals the relevance of sleep regularity for optimal mental health in interns.…”

Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine

“…Although the primary outcome of the iCOMPARE trial focused on patient safety, as reported in a companion article in this issue of the Journal , 20 the trial was designed to simultaneously assess the effects on educational experiences, which were reported previously, 21 and on the sleep and alertness of interns, which we report here. The latter aim was to establish whether sleep and alertness among interns in flexible programs were noninferior to those among interns in standard programs according to pre-specified noninferiority margins.…”

Medicine’s dangerous optimism: lessons from Dr Pangloss

“…To address the duty-hour question, two trials have recently been performed on surgery and internal medicine residents. 8,9 The trials were designed as ‘non-inferiority’ studies, a low bar in which longer shifts need only show not substantially worse patient mortality than shorter shifts. ‘Shorter’ shifts (up to 16 – 28 hours) are still longer than in the majority of professional jobs, yet they were disfavoured from the start by the non-inferiority design.…”